MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to patient complaint of distorted not clear vision to right eye.The lens was replaced with a non-johnson & johnson (panoptix) iol.The patient is happy with the new lens.No incision enlargement, vitrectomy or sutures were required.No other information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: received new information that the issue was that initial post-op was sharp/very clear.But as time went by, sees halos/haze.Can read street signs but not so clear.Pre-op vision refraction: right eye (od), 20/20.Post-op vision refraction: od, 20/20.Follow-up refraction post lens replacement was refraction 20/20; patient very happy with replacement lenses.Fields below updated to reflect new patient codes received.Section h6: health effect: clinical code: halo.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: feb.7, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: two lenses were received inside a plastic bag stuck to pieces of styrofoam.No handpieces were returned.No way to differentiate between the lenses was received.Visual inspections for both lenses under magnification revealed that the lenses were received with a cut on the optic body, which is consistent with lens that was handled during explant.The lenses were cleaned, and no issue related to or could have contributed to visual issues were observed.No defects related to or could have contributed to visual issues were observed.The complaint issue could not be confirmed and no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13238956
• Report Number: 3012236936-2022-00084
• Device Sequence Number: 4709480
• Product Code: MFK
• UDI-Device Identifier: 05050474751262
• UDI-Public: (01)05050474751262(17)240828
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/30/2022; 03/11/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White